FDA Grants De Novo Clearance to Reflow Medical’s Spur Stent System

Reflow Medical, Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Spur Peripheral Retrievable Stent System, marking a significant advancement in the treatment of infrapopliteal artery disease. 

The device is indicated for use in patients with de novo lesions or restenosis following predilation and is specifically designed for treating chronic limb-threatening ischemia (CLTI) below the knee.

The Spur Stent System is a pioneering device, combining a self-expanding scaffold with a balloon catheter on an over-the-wire platform, and is uniquely designed to be removable.

Its innovative Retrievable Scaffold Therapy (RST) approach uses radially expandable tips to penetrate lesions, modify vessel compliance, and reduce recoil—key challenges in lower limb interventions.

The system was evaluated in the DEEPER REVEAL trial (NCT05358353), which enrolled 130 patients across 49 U.S. sites. 

The trial reported a technical success rate of 99.2%, with 97.0% of patients remaining free from major adverse limb events and perioperative death at 30 days. 

These positive results supported the FDA’s decision to grant de novo approval.

Reflow Medical now plans to make the Spur Stent System immediately available through its commercial channels, expanding therapeutic options for physicians treating complex peripheral artery disease.

The FDA's de novo approval of the Spur Stent System introduces a first-of-its-kind retrievable stent, offering a new, clinically proven solution for patients with challenging below-the-knee vascular conditions.